5. Claim Requirements

5 Mins to read

Share
Dark
Light

Article summary

Did you find this summary helpful?

Thank you for your feedback

Cosmetics
South Korea

This section provides information on the definition of different types of claims and any restrictions or allowance of claims as well as claim registration processes.

5.1 Overview of Claims

Claims should be in line with the definition of cosmetics in Article 2 of the Cosmetics Act [1].

In order to use some specific claims, cosmetics must be approved as functional cosmetics as defined in Article 2 of the Enforcement Rules of the Cosmetic Act [2].

Paragraph 1 of Article 13 of the Cosmetics Act defines what should not be claimed and its detail is written in table 5 of the Enforcement Rule of the Cosmetics Act.

Article 14 of the Act demands that business operators substantiate the facts of claims.

5.1.1 Allowed Claims

1. Claims supported by demonstration data

Substantiation test/methods: Demonstration data (in vivo & in vitro) requirement is written in Regulations on the Demonstration of Labeling and Advertisement for Cosmetic Products [3,4].

2. Natural/organic cosmetic

Required documents [4]:

Business representative's oath
Business Registration
Information on the raw materials used in the product for which certification is applied
Formula Sheet (Excel table)
Organic certificate
Specifications or product standards for the product subject to certification application
MSDS for each raw material, Manufacturing process chart, and raw material usage questionnaire
Information on the manufacturing process, container, packaging and storage of the product subject to certification application
Manufacturing process diagram of the product subject to certification application
Data to check product container and packaging materials
Data on cleaning agents for workplaces and Manufacturing facilities

3. Ingredient efficacy (not to claim medical efficacy and not to confuse consumers that the ingredient efficacy is that of the cosmetic product)

Required document: Manufacturing certificate [4]

4. Free of xxx (as long as it is not on the negative list for cosmetic ingredients)

Required document: Analysis test result [4]

5. Patent (as long as it is within the allowed claim for cosmetics)

Required document: Patent certificate [4]

5.1.2 List of Prohibited Claims

Prohibited claims as explained in paragraph 1 of Article 13 of the Cosmetics Act [1]:

1. Labeling or advertisements likely to mislead consumers into thinking the cosmetics are medicines.

2. Labeling or advertisements likely to mislead consumers into thinking any cosmetic other than a functional cosmetic is a functional cosmetic, or labeling or advertisements different from the examination results of its safety and efficacy.

3. Labeling or advertisements likely to mislead consumers into thinking any cosmetic other than a natural or organic cosmetic is a natural or organic cosmetic.

4. Other labeling or advertisements likely to deceive or mislead consumers by misrepresentation (table 5 of the Enforcement Rule of the Cosmetics Act [2]):

A doctor, dentist, oriental medical doctor, pharmacist, medical institution, or other person is designating, certifying, recommending, guiding, researching, developing, or using this product.
Foreign products that may be misperceived as domestic products or domestic products as foreign products.
Technical partnerships with foreign countries and do not display or advertise technical partnerships with foreign countries.
Compares competitive products, the object and standard of comparison must be clearly stated and only matters that can be objectively confirmed must be labeled and advertised, and absolute expressions such as “best” or “best” that imply exclusivity must not be labeled or advertised.
"No animal tests" since animal test for cosmetics is prohibited in Korea.
"xxx ingredient free" if the ingredient is on the negative list for cosmetic ingredients.

5.1.3 Specific Claims [3,4]

Specific claims	Substantiation test/methods
Suitable for acne-prone skin	Data from a human study (in vivo)
Antibacterial (cleansing product only, tested bacteria must be stated)	Data from a human study (in vivo)
Anti-aging	Data from a human study (in vivo) or data from a non-human study (in vitro)
Temporary cellulite reduction	Data from a human study (in vivo)
Relieves swelling and eye bag	Data from a human study (in vivo)
Improves skin blood circulation	Data from a human study (in vivo)
Collagen increases, decreases, or activation (limited to smoothing or improving skin wrinkles functional cosmetic)	Data from a human study (in vivo), data from a non-human study(in vitro), research data at an equivalent or higher level.
Enzyme increases, decreases, or activation (limited to smoothing or improving skin wrinkles functional cosmetic)	Data from a human study(in vivo), data from a non-human study(in vitro), research data at an equivalent or higher level.
Helps improve skin barrier damage	Data from a human study (in vivo)
Regulates skin sebum secretion	Data from a human study (in vivo)
Blocking fine dust, preventing fine dust adsorption	Data from a human study (in vivo)
Improves hair damage	Data from a human study (in vivo) or data from a non-human study (in vitro)
Helps relieve blemishes and freckles (limited to skin whitening functional cosmetic)	If it is skin whitening functional cosmetic.
xx % improved	Data from a human study (in vivo) or data from a non-human study (in vitro)
xx efficacy proved from xxx clinic	Data from a human study (in vivo) or data from a non-human study (in vitro)
x% improved compared to xx (limited to own product)	Data from a human study (in vivo) or data from a non-human study (in vitro)
x% natural/organic (based on ISO 16128)	Demonstration data of final product

5.2 Other Notes or Requirements for Claims

MFDS monitors cosmetic advertisements and can request data on the claim within 15 days from written notice.

The scope and requirements of the evidentiary data include:

Test results: the demonstration data shall be human-applying test data, non-human test data, or the investigation data whose level is equal to or higher than that of the former two test data.
Investigation results: the sample selection, questionnaire, and question strategies shall coincide with the purpose or statistical methods of such investigation.
Demonstration methods: the methods of testing or investigations used for demonstration shall be either widely known in the academic circle or generally recognized in the relevant industrial sector, and shall be scientific and objective methods.

The above should have the following:

Methods of proof
Name, representative's name, address, and telephone number of the test and investigation institution.
Demonstration content and results
Where not wishing to disclose any part of demonstration data because that part belongs to trade secrets, the content of such part and the reason for disclosure.

More details can be found in the Regulations on the Demonstration of Labeling and Advertisement for Cosmetic Products [3].

Article 4 of the above regulation mentions the requirement for test results which includes:

Supervision of physician or a doctor of oriental medicine.
Voluntary participation agreement form for the human study test subjects.

The above 2 are the most common failure reasons for human-applying tests from overseas institutions/clinics.

MFDS published the Labeling and Advertisement Guideline and the Korea Cosmetic Association provides advertising advice service (paid service, KRW 40,000 to KRW 120,000 per product. See website: https://kcia.or.kr/home/main/